PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Hepa-Merz 3000 (Hepa-Merz 3g Granulate)
3 g/5 g, granules for oral solution
Ornithini aspartas
Hepa-Merz 3000 and Hepa-Merz 3g Granulate are different trade names for the same medicinal product.
Please read the following information carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Hepa-Merz 3000 is and what it is used for
Important information before taking Hepa-Merz 3000
How to take Hepa-Merz 3000
Possible side effects
How to store Hepa-Merz 3000
Contents of the pack and other information

1. What Hepa-Merz 3000 is and what it is used for

Hepa-Merz 3000 is used in the treatment of covert and overt hepatic encephalopathy
occurring in the course of chronic liver diseases, such as chronic hepatitis, liver cirrhosis.

2. Important information before using Hepa-Merz 3000

When not to use Hepa-Merz 3000
Do not use Hepa-Merz 3000 in patients with the following conditions:

hypersensitivity to L-ornithine L-aspartate, Sunset Yellow FCF (E 110), or any of the other ingredients of the medicine;
severe renal impairment (serum creatinine concentration above 3 mg/100 ml);
amino acid metabolism disorders involved in the urea cycle, e.g. due to enzymatic defects;
fructose intolerance.

Warnings and precautions
Hepa-Merz 3000 contains a colouring agent – Sunset Yellow FCF (E 110) – which may cause
allergic reactions (including asthma symptoms). This type of allergy is particularly common in
individuals sensitive to acetylsalicylic acid.
Hepa-Merz 3000 contains fructose (1.13 g per sachet, equivalent to 0.11 bread units). This should be
taken into account in patients with diabetes.
Prolonged use of Hepa-Merz 3000 may cause dental caries.
Children:
There is a lack of data on the use of this medicine in children.
Before administering the medicine to infants or children, it is essential to consult a physician, as
there may be an undiagnosed fructose intolerance in the child.
Hepa-Merz 3000 and other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as
any medicines you plan to take.
No interactions between Hepa-Merz 3000 and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a
child, you should consult your doctor before using this medicine.
Pregnancy:
There are insufficient studies on the safety of Hepa-Merz 3000 during pregnancy; therefore, use of
the medicine should be avoided during pregnancy. Hepa-Merz 3000 may be taken by pregnant
women only if recommended by a doctor.
Breastfeeding:
It is unknown whether L-ornithine L-aspartate (the active substance in Hepa-Merz 3000) passes
into human milk. Use of the medicine should be avoided during breastfeeding. Hepa-Merz 3000
may be taken by breastfeeding women only if recommended by a doctor.
Driving and operating machinery
The ability to drive motor vehicles and operate machinery may be impaired due to the underlying
disease for which Hepa-Merz 3000 is used in treatment.
Hepa-Merz 3000 contains Sunset Yellow FCF (E 110) and fructose.
See section "Warnings and precautions".

3. How to use Hepa-Merz 3000

This medicine should always be used as directed by the physician. In case of doubt, consult a
physician or pharmacist.
The usual dose is 1 or 2 sachets 1 to 3 times daily. The contents of the sachet should be dissolved
in a glass of water. Take during or after meals.
If the patient feels that the effect of the medicine is too strong or too weak, they should contact
a physician or pharmacist.
Route of administration
Oral administration.
Use of a higher than recommended dose of Hepa-Merz 3000
Symptoms of poisoning following overdose of Hepa-Merz 3000 have not been observed so far. In
the event of overdose, symptomatic treatment should be applied.
Missed dose of Hepa-Merz 3000
The next dose should be taken at the correct time, according to the dosing instructions. Do not
take a double dose to make up for a missed dose. In case of doubts regarding the use of the
medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Uncommon adverse reactions (occurring in fewer than 1 in 100 people): nausea;
vomiting; stomach pain; bloating; diarrhoea.
Very rare adverse reactions (occurring in fewer than 1 in 10,000 people): limb pain.
The above-mentioned adverse reactions are usually transient and do not necessitate discontinuation
of the medicine.
The excipient - Sunset Yellow FCF (E 110) may cause allergic reactions.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Hepa-Merz 3000

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Hepa-Merz 3000 contains
The active substance is L-ornithine L-aspartate.
Each sachet (5 g of granules) contains 3 g of L-ornithine L-aspartate.
Excipients: citric acid, lemon flavouring agent, orange flavouring agent, sodium saccharin, sodium cyclamate,
Orange Yellow S (E 110), povidone K 25, fructose.

What Hepa-Merz 3000 looks like and contents of the pack
Hepa-Merz 3000 is an orange-coloured granule.
Pack sizes: 10 or 30 sachets of 5 g.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Austria, country of export:
Merz Pharma Austria GmbH
Guglgasse 17
1110 Vienna
Austria

Manufacturer:
Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstraße 100
D-60318 Frankfurt
Germany

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Marketing authorisation number in Austria, country of export: 1-20706
Parallel import authorisation number: 18/22